Passive reuse prevention syringe that uses a flange lock

ABSTRACT

A syringe assembly includes a syringe barrel having an inside surface defining a chamber, an open proximal end, a distal end, and an outlet; a plunger assembly disposed at least partially within the syringe barrel, including an elongate plunger rod having a locking flange formed thereon; and a plunger head having a distal sealing surface, the plunger rod being engageable with the plunger head such that the plunger rod is adapted to move the plunger head within the chamber of the syringe barrel through an injection cycle; and a flange lock disposed at the open proximal end of the barrel. The flange lock is integral with the open proximal end of the syringe barrel. During the injection cycle, the flange lock engages the locking flange of the plunger rod so as to prevent removal of the plunger rod from the syringe barrel.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a passive reuse prevention syringe thatuses a flange lock. More specifically, aspects of the present inventionrelate to a syringe that includes a flange lock disposed at an openproximal end of a syringe barrel for engaging a locking flange disposedon a plunger rod. The flange lock engages the locking flange so as toprevent removal of the plunger rod from the syringe barrel and disablethe syringe.

2. Description of Related Art

Hypodermic syringe products are generally intended for a single useonly, in part, to address concerns related to the spread of diseaseassociated with reuse of such products and to deter other misuse.Attempts have been made to provide a solution to these concerns. Some ofthese attempts have provided injection systems that require a specific,affirmative act to destroy the syringe after the intended injectioneither by using a separate device for destroying the syringe orproviding a syringe assembly with frangible zones so that the syringecould be rendered inoperable by the application of force. Although manyof these devices work quite well, they do require the specific intent ofthe user followed by the affirmative act to destroy or render thesyringe inoperable. These devices are not effective with a user havingthe specific intent to reuse the hypodermic syringe.

Attempts have also been made to provide a syringe assembly that isautomatically disabled or rendered inoperable after a single or selectnumber of uses. Such syringe assemblies present specific challengesbecause they must not prevent filling or use under normal conditions.Moreover, certain automatic locking and disabling devices only allow fora fixed dosage amount to be supplied by the syringe before the syringeis disabled.

SUMMARY OF THE INVENTION

Accordingly, there is a general need for a single use syringe thatincludes a locking and disabling mechanism that does not operateautomatically but that is passively activated through normal use of thesyringe. Consequently, a user who has the specific intent to reuse thesyringe will actuate the mechanism through normal use of the syringewithout consciously realizing that the syringe has been disabled. Such amechanism will limit the ability of users to reuse the syringe whileavoiding the unnecessary costs and dosage limitations of automaticdevices.

The present invention overcomes many of the deficiencies present in theprior art by providing a syringe that offers the utility of atraditional syringe along with reuse prevention features and requiring alow force required to activate the reuse prevention mechanism. Accordingto an embodiment of the present invention, the syringe includes apassive reuse prevention mechanism that is activated by the user throughnormal use of the syringe though the user may not be aware or realizethat the mechanism has been activated. The syringe allows for variabledosing, which is important for some procedures, but can also be adaptedto deliver fixed doses if required and can be used for injections and/orreconstitution of dry drugs. The syringe is scaleable from the smallestsyringe sizes to the largest syringe sizes and allows for reductions ofcost compared to current reuse prevention syringes. The syringe isprovided with a one or two piece plunger assembly having a sealingsurface on a plunger head and a plunger rod, which is engaged by theflange lock on the syringe barrel. Upon or just prior to final injectionof the contents of the syringe, the syringe is rendered disabled due tothe engagement between flange lock and a locking flange on the plungerrod.

According to an embodiment of the present invention, a syringe assemblyis provided. The syringe assembly includes a syringe barrel having aninside surface defining a chamber, an open proximal end, a distal end,and an outlet disposed adjacent the distal end in fluid communicationwith the chamber; a plunger assembly disposed at least partially withinthe syringe barrel, including an elongate plunger rod having a proximalend, a distal end, and a locking flange formed thereon between theproximal and distal ends; a plunger head having a distal sealingsurface, the plunger rod being engageable with the plunger head suchthat the plunger rod is capable of moving the plunger head within thechamber of the syringe barrel through an injection cycle; and a flangelock disposed at the open proximal end of the barrel. During theinjection cycle, the flange lock engages the locking flange of theplunger rod so as to prevent removal of the plunger rod from the syringebarrel.

The flange lock includes a plurality of flexible protrusions distributedaround a periphery of the open proximal end of the syringe barrel. Theprotrusions are integral with the open proximal end of the syringebarrel and may extend proximally from the open proximal end of thesyringe barrel or distally from the open proximal end of the syringebarrel into the chamber of the barrel. The syringe barrel furtherincludes an outwardly extending flange at the open proximal end thereof.

The plunger rod has a cylindrical shape defining an outer surface andthe flexible protrusions of the flange lock are adapted to flex towardthe inside surface of the barrel as the plunger rod is inserted into thechamber of the barrel. During the injection cycle, the protrusions slidealong the outer surface of the plunger rod and engage the locking flangeon the plunger rod so as to retain the plunger assembly in a bottomedout position and disable the syringe assembly.

The locking flange on the plunger rod tapers outwardly from the outersurface of the plunger rod so as to form a distally facing beveledsurface and a proximally facing abutment surface. Ends of the flexibleprotrusions slide over the distally facing beveled surface of thelocking flange during the injection cycle and engage the proximallyfacing abutment surface so as to retain the plunger assembly in thebottomed out position. The plunger rod further includes a tamperprevention disk located proximal to the locking flange so as to preventtampering with the engagement between the locking flange and the flangelock and an outwardly extending flange at a proximal end thereof. Theplunger rod has a variable diameter and tapers inwardly toward theflange lock.

The plunger head further includes a distal wall, the distal wall havingthe distal sealing surface defined thereon; a proximal wall, spaced fromthe distal wall; and a central portion extending between the distal walland the proximal wall, the central portion having a cylindrical coreportion and a plurality of equally spaced fin portions extendingradially from the cylindrical core portion. The distal wall of theplunger head perimetrically engages the inner surface of the barrel soas to seal the chamber of the barrel.

The distal end of the plunger rod is slidably connected to the plungerhead such that during the injection cycle the plunger rod slides withrespect to the plunger head. The plunger head includes a cylindricalconnecting portion extending from the proximal wall of the plunger head,the cylindrical connecting portion having an annular lip at a proximalend thereof. The plunger rod has a hollow cylindrical shape defining anouter surface and an inner diameter, the inner diameter of the plungerrod having an internal annular ring adapted to engage the annular lip ofthe cylindrical connecting portion such that the internal annular ringof the plunger rod is able to slide over the annular lip in the distaldirection and retain the annular lip of the cylindrical connectingportion within the plunger rod. The plunger rod slides with respect tothe cylindrical connecting portion of the plunger head such that theinternal annular ring of the plunger rod engages the annular lip of thecylindrical connecting portion during aspiration and the distal end ofthe plunger rod engages the proximal wall of the plunger head duringinjection. A force necessary to advance the plunger rod relative to theplunger head during the injection cycle between aspiration and injectionis less than a force necessary to sustain injection.

The plunger rod further includes an annular flange extending from theouter surface of the plunger rod at the distal end of the plunger rod,the annular flange having a diameter slightly less than or equal to adiameter of the inside surface of the syringe barrel. The plunger headmay be made from a plastic material or an elastomeric material.

According to a further aspect of the present invention, a method ofactuating a syringe assembly is provided. The method includes the stepof providing a syringe assembly that includes a syringe barrel having aninside surface defining a chamber, an open proximal end, a distal end,and an outlet disposed adjacent the distal end in fluid communicationwith the chamber; a plunger assembly disposed at least partially withinthe syringe barrel, including an elongate plunger rod having cylindricalshape defining an outer surface, a proximal end, a distal end, and alocking flange formed thereon between the proximal and distal ends; aplunger head having a distal sealing surface; and a flange lock disposedat the open proximal end of the barrel, the flange lock including aplurality of flexible protrusions extending proximally from the openproximal end of the syringe barrel and distributed around a periphery ofthe open proximal end of the syringe barrel. The plunger head isinserted into the chamber of the syringe barrel to a position proximateto the distal end of the syringe barrel such that the protrusions of theflange lock fold into the chamber toward the inside surface of thesyringe barrel and spring back after insertion of the plunger head iscompleted. The plunger rod is inserted into the chamber of the syringebarrel such that the protrusions of the flange lock fold into thechamber toward the inside surface of the syringe barrel and are held ina folded position by the outer surface of the plunger rod. The distalend of the plunger rod is connected with the plunger head such that theplunger rod is slidable with respect to the plunger head. The plungerassembly is drawn from the position proximate to the distal end of thesyringe barrel in a proximal direction with the plunger head in anextended position from the distal end of the plunger rod so as toaspirate the chamber of the syringe barrel. The plunger assembly isadvanced within the chamber of the syringe barrel so that the plungerrod slides with respect to the plunger head to a collapsed position withrespect to the plunger head. The plunger assembly is further advancedwithin the chamber of the syringe barrel. The locking flange on theplunger rod is engaged with the protrusions of the flange lock so as toretain the plunger assembly in a locked position at least partiallywithin the chamber of the syringe barrel and disable the syringeassembly.

Further details and advantages of the invention will become clear uponreading the following detailed description in conjunction with theaccompanying drawing figures, wherein like parts are designated withlike reference numerals throughout.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of a passive reuse prevention syringe assembly inaccordance with an embodiment of the present invention.

FIG. 2 is a side view of a syringe barrel and flange lock of the syringeassembly shown in FIG. 1.

FIG. 3 is a rear perspective view of the syringe barrel and flange lockof FIG. 2.

FIG. 4 is a rear view of the syringe barrel and flange lock of FIG. 2.

FIG. 5 is a rear perspective view of a plunger rod of the syringeassembly shown in FIG. 1.

FIG. 6 is a side view of the plunger rod of FIG. 5.

FIG. 7 is a rear perspective view of a plunger head of the syringeassembly shown in FIG. 1.

FIG. 8 is a side view of the plunger head of FIG. 7.

FIG. 9 is a side view of the syringe barrel and flange lock and theplunger head of the syringe assembly prior to insertion of the plungerhead into the chamber of the syringe barrel.

FIG. 10 is a side view of the syringe barrel and flange lock and theplunger head of the syringe assembly as the plunger head is insertedinto the chamber of the syringe barrel.

FIG. 11 is a partial cross-sectional side view of the syringe barrel andflange lock and the plunger head of the syringe assembly showing theplunger head in a bottomed out position within the chamber of thesyringe barrel.

FIG. 12 is a partial cross-sectional side view of the syringe assemblyas the plunger rod is inserted into the chamber of the syringe barrel.

FIG. 13 is a partial cross-sectional side view of the syringe assemblyas the plunger rod is inserted further into the chamber of the syringebarrel.

FIG. 14 is a partial cross-sectional side view of the syringe assemblyprior to aspiration of the syringe barrel as the plunger rod engages theplunger head.

FIG. 15 is an enlarged partial cross-sectional side view of the syringeassembly after completion of an injection cycle showing the plungerassembly in a locked position.

FIG. 16 is an enlarged partial side view of the syringe assembly of FIG.15 further illustrating an engagement between the flange lock and theplunger rod.

FIG. 17 is an enlarged partial cross-sectional side view of the syringeassembly of FIG. 15 further illustrating an engagement between theplunger rod and the plunger head.

DESCRIPTION OF PREFERRED EMBODIMENTS

For purposes of the description hereinafter, spatial orientation terms,if used, shall relate to the referenced embodiment as it is oriented inthe accompanying drawing figures or otherwise described in the followingdetailed description. However, it is to be understood that theembodiments described hereinafter may assume many alternative variationsand embodiments. It is also to be understood that the specific devicesillustrated in the accompanying drawing figures and described herein aresimply exemplary and should not be considered as limiting.

Referring to FIG. 1, a syringe assembly 10 according to an embodiment ofthe present invention is shown. The syringe assembly 10 includes asyringe barrel 20 and a plunger assembly 30. As shown in FIGS. 1-4, thesyringe barrel 20 has an open proximal end 23 and a distal end 21opposite to the open proximal end 23. The syringe barrel 20 has aninside surface 24, which defines a chamber 25. The syringe barrel 20also includes an outlet 11 disposed on the distal end 21 of the syringebarrel 20. The outlet 11 is in fluid communication with the chamber 25of the syringe barrel 20. A needle cannula 12 may be attached to theoutlet 11 such that an interior of the needle cannula 12 is in fluidcommunication with the chamber 25 of the syringe barrel 20. As shown,the syringe barrel 20 may have a cylindrical or substantiallycylindrical shape, and may include an outwardly extending flange 22 atthe open proximal end 23, though it is to be appreciated that thesyringe barrel 20 may be formed in any suitable shape. Additionally, thesyringe barrel 20 may be injection molded from thermoplastic materialsuch as polypropylene and polyethylene according to techniques known tothose of ordinary skill in the art, though it is to be appreciated thatthe syringe barrel 20 may be made from other suitable materials andaccording to other applicable techniques.

Also as shown in FIG. 1, the needle cannula 12 may be secured within theoutlet 11 by a chemical adhesive, such as epoxy, or may be mechanicallyaffixed to the outlet 11 according to known techniques. For instance,the outlet 11 may be modified to receive a separate needle hub thereonvia a standard luer taper fitting or luer lock fitting. The syringeassembly 10 may also include a protective cap (not shown) disposed overthe outlet 11 to protect the needle cannula 12 prior to use and toprevent accidental needle sticks of persons handling the syringeassembly 10 prior to use. An annular ridge 13 may be formed on thedistal end 21 of the syringe barrel 20 to facilitate attachment of aprotective cap or a standard needle hub over the outlet 11.

With further reference to FIGS. 1-4, a flange lock 26 is disposed at theopen proximal end 23 of the barrel 20. The flange lock 26 includes aplurality of flexible protrusions 27 distributed around a periphery ofthe open proximal end 23 of the syringe barrel 20 and extend from theopen proximal end 23 of the syringe barrel 20 to free ends 271. Asshown, the protrusions 27 are integral with the open proximal end 23 ofthe syringe barrel 20, though it is to be appreciated that the flangelock 26 and protrusions 27 may be formed separately and attached to thesyringe barrel 20 by techniques known to those of ordinary skill in theart. As shown in FIGS. 2-4, in an initial condition, the protrusions 27extend proximally from the open proximal end 23 of the syringe barrel20. As shown in FIGS. 1 and 16, the protrusions are adapted to be foldedto extend distally into the chamber 25 and flex toward the insidesurface 24 of the syringe barrel 20. Alternatively, the flange lock 26may be formed such that the protrusions 27 extend distally into thechamber 25 or parallel to the open proximal end 23 of the barrel 20 inan initial condition.

With reference to FIGS. 1, 5, and 6, the plunger assembly 30 is disposedat least partially within the syringe barrel 20. The plunger assembly 30includes an elongate plunger rod 31 having a cylindrical shape definingan outer surface 39. The plunger rod 31 has a proximal end 311 definedby an outwardly extending flange 36 and a distal end 312 defined by anannular flange 32. A locking flange 34 is formed on the plunger rod 31between the proximal 311 and distal 312 ends. Specifically, the lockingflange 34 is located on the plunger rod 31 approximately two-thirds ofthe length of the plunger rod 31 from the distal end 312 of the plungerrod 31 such that the plunger rod 31 may be inserted nearly the fulllength of the chamber 25 of the syringe barrel 20 without engaging theflange lock 26.

As shown in FIGS. 5 and 6, the locking flange 34 tapers outwardly fromthe outer surface 39 of the plunger rod 31 so as to form a distallyfacing beveled surface 341 and a proximally facing abutment surface 342.A large diameter portion 343 of the plunger rod 31 is located directlyproximal of the proximally facing abutment surface 342 of the lockingflange 34. The plunger rod 31 also includes tamper prevention disk 35located proximal to the locking flange 34. The plunger rod 31 has avariable diameter. Specifically, the plunger rod 31 includes a portion33 that tapers inwardly toward the locking flange 34. The plunger rod 31also includes a uniform diameter portion 331 located between theinwardly tapering portion 33 and the distally facing beveled surface 341of the locking flange 34. The plunger rod 31 may be inserted into thechamber 25 of the syringe barrel 20 in a packaged state. Preferably, inthe packaged condition, the plunger rod 31 will be inserted into thesyringe barrel 20 such that the protrusions 27 expand to conform to theinwardly tapering portion 33 and/or the uniform diameter portion 331 ofthe plunger rod 31, i.e., the portion of the plunger rod 31 having thesmallest diameter. This reduces deformation of the protrusions 27 priorto use so as to ensure that the protrusions 27 will be sufficientlyelastic to engage the large diameter portion 343 and the proximallyfacing abutment surface 342 of the locking flange 34 to prevent removalof the plunger rod 31 from the syringe barrel 20.

As shown in FIGS. 14-16, the tamper prevention disk 35 is sized andspaced from the locking flange 34 such that the tamper prevention disk35 prevents healthcare workers and others from tampering with anengagement between the flange lock 26 on the syringe barrel 20 and thelocking flange 34. Also, as shown in FIGS. 15 and 17, the plunger rod 31is hollow and has an inner diameter 37. The inner diameter 37 of theplunger rod 31 includes an internal annular ring 38 adjacent to thedistal end 312 of the plunger rod 31. Further, the annular flange 32 atthe distal end 312 of the plunger rod 31 has a diameter slightly lessthan or equal to the diameter of the inside surface 24 of the syringebarrel 20, such that the flange 32 is able to engage against the freeends 271 of the protrusions 27 of the flange lock 26 to prevent removalof the plunger rod 31 from the syringe barrel 20. The annular flange 32also stabilizes the position of the plunger rod 31 within the syringebarrel 20 and facilitates alignment of the distal end 312 of the plungerrod 31 within the chamber 25 and the connection to plunger head 40, aswill be discussed below.

With reference to FIGS. 7 and 8, the plunger assembly 30 also includes aplunger head 40. The plunger head 40 includes a distal wall 41 and aproximal wall 42. The distal wall 41 has a distal sealing surface 46 ofthe plunger head 40 defined thereon. As shown in FIGS. 15 and 17, thedistal wall 41 of the plunger head 40 perimetrically engages the insidesurface 24 of the syringe barrel 20 so as to seal the chamber 25 of thesyringe barrel 20 during use of the syringe assembly 10. The distal andproximal walls 41, 42 of the plunger head 40 are spaced by a centralportion 43 of the plunger head 40 that extends between the distal andproximal walls 41, 42 of the plunger head 40. The central portion 43 hasa cylindrical core portion 45 and a plurality of fin portions 44extending radially from the cylindrical core portion 45, which may beequally spaced about the cylindrical core portion 45. As shown, thereare four fin portions 44, though there could be more or less so long asthe distal wall 41 of the plunger head 40 is suitably supported againstcanting, thus breaking a sealing engagement between the distal wall 41and the inside surface 24 of the syringe barrel 20 during use.

As shown in FIGS. 7 and 8, the plunger head 40 further includes acylindrical connecting portion 47 extending from the proximal wall 42 ofthe plunger head 40. The cylindrical connecting portion 47 includes anannular lip 48 at a proximal end thereof. As shown, the cylindricalconnecting portion 47 is integrally connected to the proximal wall 42 ofthe plunger head 40 by a neck portion 49. It is to be appreciated thatthe cylindrical connecting portion 47 may be formed separately from theplunger head 40 and attached to the proximal wall 42 of the plunger head40 by an adhesive or may be mechanically affixed to the proximal wall 42according to known techniques.

The plunger head 40 may be integrally molded from either a soft plasticmaterial, such as polyurethane, or alternatively may be formed from arubber or elastomeric material depending upon choice. Such versatilityand interchangeability within the syringe assembly 10 is advantageousbecause all plastic components can be used in markets where cost isextremely important and an elastomeric plunger head 40 can be used inmarkets with a strong preference for such components. It is to beappreciated that the plunger head can be formed in different shapes andaccording to other techniques known to be suitable to those of ordinaryskill in the art.

As shown in FIGS. 13-15 and 17, the distal end 312 of the plunger rod 31is engageable with the cylindrical connecting portion 47 of the plungerhead 40 so that the plunger rod 31 is able to move the plunger head 40within the chamber 25 of the syringe barrel 20 through an injectioncycle. Particularly, the distal end 312 of the plunger rod 31 isslidably connected to the plunger head 40 such that during the injectioncycle the plunger rod 31 slides with respect to the plunger head 40. Thecylindrical connecting portion 47 fits within the inner diameter 37 ofthe hollow plunger rod 31 such that the internal annular ring 38 of theplunger rod 31 is able to engage the annular lip 48 of the cylindricalconnecting portion 47 by sliding over the annular lip 48 in the distaldirection and thereafter retain the annular lip 48 of the cylindricalconnecting portion 47 with the plunger rod 31 so as to slidably connectthe distal end 312 of the plunger rod 31 with the plunger head 40.During an injection cycle, the distal end 312 of the plunger rod 31slides with respect to the cylindrical connecting portion 47 of theplunger head 40 such that the internal annular ring 38 of the plungerrod 31 engages the annular lip 48 of the cylindrical connecting portion47 during aspiration of the syringe barrel 20 and the distal end 312 ofthe plunger rod 31 passes over the cylindrical connecting portion 47 andabuttingly engages the proximal wall 42 of the plunger head 40 duringinjection of the contents of the syringe barrel 20.

Referring to FIGS. 9-17, operation of the syringe assembly 10 accordingto an embodiment of the present invention will now be described indetail. As shown in FIGS. 9-11, at an initial state of the syringeassembly 10, the plunger head 40 is inserted into the chamber 25 of thesyringe barrel 20 via the open proximal end 23 to a position proximateto the distal end 21 of the syringe barrel 20, particularly a bottomedout position within the chamber 25. As the plunger head 40 is insertedinto the chamber 25, the protrusions 27 of the flange lock 26 will foldinto the chamber 25 toward the inside surface 24 of the syringe barrel20. Once the plunger head 40 passes through the flange lock 26, theprotrusions 27 may spring back into their initial condition. It is to beappreciated that the syringe assembly 10 may be packaged with theplunger head 40 already fully inserted into the chamber 25 of thesyringe barrel 20 and with the plunger rod 31 inserted into the chamber25 of the syringe barrel 20 and attached to the plunger head 40, asshown in FIG. 14. Alternatively, the plunger head 40 and the plunger rod31 may be packaged separately from the syringe barrel 20 and thenmanually inserted by a healthcare worker or technician prior to use.

As shown in FIGS. 12-14, the plunger rod 31 is then inserted into thechamber 25 via the open proximal end 23 of the syringe barrel 20 so asto be disposed at least partially within the chamber 25. As the plungerrod 31 is inserted into the chamber 25, the protrusions 27 of the flangelock 26 fold into the chamber 25 toward the inside surface 24 of thesyringe barrel 20 and are held in a folded position by the outer surface39 of the plunger rod 31. As the plunger rod 31 is further inserted intothe chamber 25, the distal end 312 of the plunger rod 31 will come intoengagement with the cylindrical connecting portion 47 of the plungerhead 40, as discussed above, so as to connect the distal end 312 of theplunger rod 31 with the plunger head 40 such that the plunger rod 31 isslidable with respect to the cylindrical connecting portion 47 of theplunger head 40.

During aspiration, the plunger rod 31 is drawn from the syringe barrel20 in the proximal direction. As this occurs, the plunger rod 31 mayinitially slide with respect to the cylindrical connecting portion 47 ofthe plunger head 40 until the internal annular ring 38 of the plungerrod 31 engages the annular lip 48 of the cylindrical connecting portion47 and the plunger head 40 is drawn proximally by the plunger rod 31 inan extended position so as to aspirate the chamber 25 of the syringebarrel 20.

Once the desired aspiration of the chamber 25 of the syringe barrel 20is completed, the plunger rod 31 is advanced within the chamber 25 ofthe syringe barrel 20. As the plunger rod 31 is advanced, the distal end312 of the plunger rod 31 slides with respect to cylindrical connectingportion 47 of the plunger head 40 until the distal end 312 of theplunger rod 31 engages the proximal wall 42 of the plunger head 40 in acollapsed position. The plunger assembly 30 is then further advancedwithin the chamber 25 of the syringe barrel 20 with the plunger head 40being pushed through the chamber 24 by the distal end 312 of the plungerrod 31 so as to inject the contents of the chamber 25 into a patient.Thus, it is to be appreciated that a force necessary to advance theplunger rod 31 relative to the plunger head 40 during the injectioncycle between aspiration and injection is less than a force necessary tosustain injection of the contents of the chamber 25 of the syringebarrel 20. By providing a collapsible plunger assembly 30 with aslidable connection between the plunger rod 31 and the plunger head 40,the plunger head 40 can be initially packaged in a bottomed outcondition, i.e., abutting or adjacent to the distal end 21 of thesyringe barrel 20. This results in less air being drawn into the chamber25 of the syringe barrel 20 during aspiration and prior to injection. Itis to be appreciated that the plunger assembly 30 could alternatively beformed with the plunger head 40 integral with the plunger rod 31 orotherwise non-slidably connected to the plunger rod 31 according toknown techniques.

As shown in FIGS. 15 and 16, during the injection cycle, the protrusions27 of the flange lock 26 slide along the outer surface 39 of the plungerrod 31 and engage the locking flange 34 of the plunger rod 31 upon orsubstantially upon completion of the injection cycle so as to retain theplunger assembly 30 in a bottomed out position with the distal sealingsurface 46 of the plunger head 40 abutting, or nearly abutting, againstthe distal end 21 of the syringe barrel 20 to prevent removal of theplunger rod 31 from the syringe barrel 20, thereby retaining the plungerassembly 30 in a locked position at least partially within the chamber25 of the syringe barrel 20 and disabling the syringe assembly 10. Moreparticularly, as the plunger head 40 reaches the bottomed out positionand the contents of the chamber 25 of the syringe barrel 20 are fullyinjected to complete the injection cycle, the ends 271 of the flexibleprotrusions 27 slide over the distally facing beveled surface 341 of thelocking flange 34 and engage the proximally facing abutment surface 342so as to retain the plunger assembly 30 in the bottomed out position.Alternatively, the locking flange 34 may be positioned on the plungerrod 31 such that the locking flange 34 moves distally beyond the flangelock 26 during the injection cycle prior to full injection of thecontents of the syringe barrel 20 so as to prevent removal of theplunger rod 31 from the syringe barrel 20.

While several embodiments of a passive reuse prevention syringe thatuses a flange lock and method were described in the foregoing detaileddescription, those skilled in the art may make modifications andalterations to these embodiments without departing from the scope andspirit of the invention. Accordingly, the foregoing description isintended to be illustrative rather than restrictive. The inventiondescribed hereinabove is defined by the appended claims and all changesto the invention that fall within the meaning and the range ofequivalency of the claims are embraced within their scope.

1. A syringe assembly, comprising: a syringe barrel having an insidesurface defining a chamber, an open proximal end, a distal end, and anoutlet disposed adjacent the distal end in fluid communication with thechamber; plunger assembly disposed at least partially within the syringebarrel, comprising an elongate plunger rod having a proximal end, adistal end, a locking flange formed thereon between the proximal anddistal ends, and a plunger head, the plunger rod being engageable withthe plunger head such that the plunger rod is adapted to move theplunger head within the chamber of the syringe barrel through aninjection cycle; and a flange lock disposed at the open proximal end ofthe barrel, wherein the plunger rod has a cylindrical shape defining anouter surface extending from the distal end of the plunger rod to theproximal end of the plunger rod and the locking flange is formed on theouter surface of the plunger rod, wherein the flange lock is integralwith the open proximal end of the syringe barrel, wherein during theinjection cycle, the flange lock engages the locking flange of theplunger rod so as to prevent removal of the plunger rod from the syringebarrel, and wherein the flange lock includes a plurality of flexibleprotrusions distributed around a periphery of the open proximal end ofthe syringe barrel.
 2. The syringe assembly according to claim 1,wherein the protrusions extend proximally from the open proximal end ofthe syringe barrel.
 3. The syringe assembly according to claim 1,wherein the protrusions extend distally from the open proximal end ofthe syringe barrel into the chamber of the barrel.
 4. The syringeassembly according to claim 1, wherein the flexible protrusions of theflange lock are adapted to flex toward the inside surface of the barrelas the plunger rod is inserted into the chamber of the barrel, andduring the injection cycle, the protrusions slide along the outersurface of the plunger rod and engage the locking flange on the plungerrod so as to retain the plunger assembly in the barrel of the syringeand disable the syringe assembly.
 5. The syringe assembly according toclaim 4, wherein the locking flange on the plunger rod tapers outwardlyfrom the outer surface of the plunger rod so as to form a distallyfacing beveled surface and a proximally facing abutment surface, andends of the flexible protrusions slide over the distally facing beveledsurface of the locking flange during the injection cycle and engage theproximally facing abutment surface so as to retain the plunger assemblyin the barrel of the syringe.
 6. The syringe assembly according to claim1, wherein the plunger rod further includes a tamper prevention disklocated proximal to the locking flange so as to prevent tampering withthe engagement between the locking flange and the flange lock.
 7. Thesyringe assembly according to claim 1, wherein the plunger rod has avariable diameter.
 8. A syringe assembly, comprising: a syringe barrelhaving an inside surface defining a chamber, an open proximal end, adistal end, and an outlet disposed adjacent the distal end in fluidcommunication with the chamber; a plunger assembly disposed at leastpartially within the syringe barrel, comprising an elongate plunger rodhaving, a proximal end, a distal end, a locking flange formed thereonbetween the proximal and distal ends, and a plunger head, the plungerrod being engageable with the plunger head such that the plunger rod isadapted to move the plunger head within the chamber of the syringebarrel through an injection cycle; and a flange lock disposed at theopen proximal end of the barrel, wherein the plunger rod has acylindrical shape defining an outer surface extending from the distalend of the plunger rod to the proximal end of the plunger rod and thelocking flange is formed on the outer surface of the plunger rod,wherein the flange lock is integral with the open proximal end of thesyringe barrel, wherein during the injection cycle, the flange lockengages the locking flange of the plunger rod so as to prevent removalof the plunger rod from the syringe barrel, wherein the plunger rod hasa variable diameter, and wherein the plunger rod tapers inwardly towardthe flange lock.
 9. A syringe assembly, comprising: a syringe barrelhaving an inside surface defining a chamber, an open proximal end, adistal end, and an outlet disposed adjacent the distal end in fluidcommunication with the chamber; a plunger assembly disposed at leastpartially within the syringe barrel, comprising an elongate plunger rodhaving a proximal end, a distal end, a locking flange formed thereonbetween the proximal and distal ends, and a plunger head, the plungerrod being engageable with the plunger head such that the plunger rod isadapted to move the plunger head within the chamber of the syringebarrel through an injection cycle; and a flange lock disposed at theopen proximal end of the barrel, wherein the plunger rod has acylindrical shape defining an outer surface extending from the distalend of the plunger rod to the proximal end of the plunger rod and thelocking flange is formed on the outer surface of the plunger rod,wherein the flange lock is integral with the open proximal end of thesyringe barrel, wherein during the injection cycle, the flange lockengages the locking flange of the plunger rod so as to prevent removalof the plunger rod from the syringe barrel, and wherein the plunger headfurther comprises: a distal wall, the distal wall having a distalsealing surface defined thereon; a proximal wall, spaced from the distalwall; and a central portion extending between the distal wall and theproximal wall, the central portion having a cylindrical core portion anda plurality of fin portions extending radially from the cylindrical coreportion, and wherein the distal wall of the plunger head perimetricallyengages the inner surface of the barrel so as to seal the chamber of thebarrel.
 10. A syringe assembly, comprising: a syringe barrel having aninside surface defining a chamber, an open proximal end, a distal end,and an outlet disposed adjacent the distal end in fluid communicationwith the chamber; a plunger assembly disposed at least partially withinthe syringe barrel, comprising an elongate plunger rod having a proximalend, a distal end, a locking flange formed thereon between the proximaland distal ends, and a plunger head, the plunger rod being engageablewith the plunger head such that the plunger rod is adapted to move theplunger head within the chamber of the syringe barrel through aninjection cycle; and a flange lock disposed at the open proximal end ofthe barrel, wherein the plunger rod has a cylindrical shape defining anouter surface extending from the distal end of the plunger rod to theproximal end of the end plunger rod and the locking flange is formed onthe outer surface of the plunger rod, wherein the flange lock isintegral with the open proximal end of the syringe barrel, whereinduring the injection cycle, the flange lock engages the locking flangeof the plunger rod so as to prevent removal of the plunger rod from thesyringe barrel, wherein the distal end of the plunger rod is slidablyconnected to the plunger head, wherein the plunger head includes acylindrical connecting portion extending from a proximal wall of theplunger head, the cylindrical connecting portion having an annular lipat a proximal end thereof, the plunger rod has a hollow cylindricalshape defining an outer surface and an inner diameter, the innerdiameter of the plunger rod having an internal annular ring adapted toengage the annular lip of the cylindrical connecting portion such thatthe internal annular ring of the plunger rod is able to slide over theannular lip in the distal direction and retain the annular lip of thecylindrical connecting portion within the plunger rod, and the plungerrod slides with respect to the cylindrical connecting portion of theplunger head such that the internal annular ring of the plunger rodengages the annular lip of the cylindrical connecting portion duringaspiration and the distal end of the plunger rod engages the proximalwall of the plunger head during injection.
 11. The syringe assemblyaccording to claim 10, wherein a force necessary to advance the plungerrod relative to the plunger head during the injection cycle betweenaspiration and injection is less than a force necessary to sustaininjection.
 12. The syringe assembly according to claim 10, wherein theplunger rod further includes an annular flange extending from the outersurface of the plunger rod at the distal end of the plunger rod, theannular flange having a diameter slightly less than or equal to adiameter of the inside surface of the syringe barrel.
 13. A plungerassembly for a syringe, the plunger assembly comprising: an elongateplunger rod having a proximal end, a distal end, and a locking flangeformed thereon between the proximal and distal ends; and a plunger head,the plunger head including a cylindrical connecting portion, wherein theplunger rod is engageable with the plunger head such that the plungerrod is adapted to move the plunger head within the chamber of as nebarrel through an injection cycle, wherein the distal end of the plungerrod is slidably connected to the plunger head, wherein during theinjection cycle, the locking flange of the plunger rod is configured toengage a flange lock on the syringe so as to prevent removal of theplunger rod from the syringe barrel, wherein the plunger rod has ahollow cylindrical shape defining an outer surface and an innerdiameter, and the cylindrical connecting portion of the plunger headfits within the inner diameter of the plunger rod, and wherein theplunger head further comprises: a distal wall, the distal wall having adistal sealing surface defined thereon; a proximal wall, spaced from thedistal wall; and a central portion extending between the distal wall andthe proximal wall, the central portion having a cylindrical core portionand a plurality of fin portions extending radially from the cylindricalcore portion, wherein the distal wall of the plunger head is configuredto perimetrically engage an inner surface of the syringe barrel so as toseal a chamber of the syringe barrel.
 14. The plunger assembly accordingto claim 13, wherein the plunger rod further includes a tamperprevention disk located proximal to the locking flange so as to preventtampering with the engagement between the locking flange and the flangelock.
 15. The plunger assembly according to claim 13, wherein thelocking flange on the plunger rod tapers outwardly from the outersurface of the plunger rod so as to form a distally facing beveledsurface and a proximally facing abutment surface.
 16. A plunger assemblyfor a syringe, the plunger assembly comprising: an elongate plunger rodhaving a proximal end, a distal end, and a locking flange formed thereonbetween the proximal and distal ends; and a plunger head, the plungerhead including a cylindrical connecting portion, wherein the plunger rodis engageable with the plunger head such that the plunger rod is adaptedto move the plunger head within the chamber of a syringe barrel throughan injection cycle, wherein the distal end of the plunger rod isslidably connected to the plunger head, wherein during the injectioncycle, the locking flange of the plunger rod is configured to engage aflange lock on the syringe so as to prevent removal of the plunger fromthe syringe barrel, wherein the plunger rod has a hollow cylindricalshape defining an outer surface and an inner diameter, and thecylindrical connecting portion of the plunger head fits within the innerdiameter of the plunger rod, and wherein the cylindrical connectingportion of the plunger head extends from a proximal wall of the plungerhead and has an annular lip at a proximal end thereof, the innerdiameter of the plunger rod has an internal annular ring adapted toengage the annular lip of the cylindrical connecting portion such thatthe internal annular ring of the plunger rod is able to slide over theannular lip in the distal direction and retain the annular lip of thecylindrical connecting portion within the plunger rod, and the plungerrod slides with respect to the cylindrical connecting portion of theplunger head such that the internal annular ring of the plunger rodengages the annular lip of the cylindrical connecting portion duringaspiration and the distal end of the plunger rod engages the proximalwall of the plunger head during injection.
 17. The plunger assemblyaccording to claim 16, wherein the plunger rod further includes anannular flange extending from the outer surface of the plunger rod atthe distal end of the plunger rod.